FDA applicant
Cui Corp.
FDA records 7 decisions for Cui Corp. (Santa Barbara, CA) from 1990 to 1991: 7 510(k) clearances. Most are in product codes LZK (Implant, Malar) and FZE (Prosthesis, Nose, Internal). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cui Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cui Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cui Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report